ALISO VIEJO, Calif., December 10, 2013– Cianna Medical, Inc., a women’s health company, today announced the outcomes of a large, retrospective study demonstrating the safety and efficacy of the SAVI® breast brachytherapy applicator. Researchers reported favorably low recurrence rates, high rates of survival and excellent cosmetic outcomes. SAVI is a strut-based applicator that delivers a form of accelerated partial breast irradiation (APBI) known as breast brachytherapy, a 5-day course of targeted radiation for early-stage breast cancer.
Data came from the SAVI Collaborative Research Group (SCRG), which studies the long-term outcomes of women treated with strut-based brachytherapy, and will be presented at the 36th annual San Antonio Breast Cancer Symposium, December 10-14, 2013.
Researchers examined data from 576 patients with a median follow-up of more than 3 years. The two-year actuarial local recurrence rate was 1.17%, and overall survival over the same time period was 99.5%. During follow up, the rate of late toxicities was very low (< 5%), and 98.5% reported excellent or good cosmesis at 48 months.
“With recurrence rates comparable to whole breast irradiation, strut-based brachytherapy has proven to be an effective treatment for a certain population of early-stage breast cancer patients,” said lead author Catheryn Yashar, MD, a radiation oncologist at UC San Diego’s Moores Cancer Center, La Jolla, Calif., and co-principal investigator of the SCRG. “In addition, the ability to precisely target radiation to the tumor bed makes it a very well-tolerated treatment with fewer late toxicities and side effects compared to other forms of radiation therapy.”
In contrast, two studies were published last month in The Lancet and The Lancet Oncology journals addressing another form of APBI known as intraoperative radiation therapy (IORT). Both randomized studies compared IORT to whole breast radiation, and researchers reported rates of local recurrence with IORT that were 11 and 2.5 times higher than with whole breast radiation.
Strut-based brachtherapy is used as part of breast conservation therapy (BCT), which consists of a lumpectomy followed by radiation therapy. Traditionally, the radiation portion consisted of whole breast irradiation (WBI), which requires 6-7 weeks of daily treatments. Breast brachytherapy delivers radiation to the area immediately surrounding the lumpectomy cavity, enabling treatment to be completed in as little as 5 days and sparing healthy tissue from unnecessary radiation. Patient eligibility for breast brachytherapy is based on a number of factors, including tumor size, age, margin status and lymph node involvement.
The strut-based, open architecture design of SAVI allows physicians to sculpt radiation based on patient-specific anatomy, which may increase the number of women eligible for breast brachytherapy.
About Cianna Medical, Inc.
Cianna Medical, Inc. is a medical device company focused on women's health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The applicator allows precise sculpting of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women.